Biliary drainage strategy in Malignant Extrahepatic Biliary Obstruction Multi-Hole Self-expandable Metal Stent, Fully-covered Self-expandable Metal Stent, Malignant Extrahepatic Biliary Obstruction
Conditions
Interventions
MHSEMS is a novel SEMS with multiple small side holes on the covering membrane to prevent stent migration while minimizing tumor ingrowth,FCSEMS are composed of a metal alloy tubular mesh with a synth
Experimental Device,Experimental Device
MHSEMS,FCSEMS
Sponsors
Excellence Center For GI Endoscopy, King Chulalongkorn Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 year-old 2. Patients with malignant extra-hepatic biliary obstruction diagnosed from endoscopic ultrasound, radiology or histopatholohy 3. Location of biliary obstruction located below hilar region more than 1 centimeter 4. The patient had never received prior biliary drainage intervention
Exclusion criteria
Exclusion criteria: 1. Patients with uncorrectable coagulopathy (platelet < 50,000 per mm3, INR >1.5) 2. Altered surgical anatomy related to pancreatico-biliary regions 3. Inaccessible to ampulla 4. Pregnancy 5. Contraindicated to ERCP 6. Terminally illed patients with expected life expectancy less than 3 months 7. The patient who denied or could not sign the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent biliary obstruction until event occur biochemical testing (relapsed obstructive jaundice) and radiologic confirmation of recurrent biliary obstruction | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of stent migration until event occur or dead Radiological assessment,Clinical success in biliary drainage 2 weeks Decreased in total bilirubin more than 50% within 2 weeks after the intervention,Cause of recurrent biliary obstruction Until event occurs or dead Clinical assessment,Adverse event until event occurs or dead clinical assessment | — |
Countries
Thailand
Contacts
Public ContactRungsun Rerknimitr
King Chulalongkorn Memorial Hospital
Outcome results
None listed